The phase 3, multicenter trial tracked 274 patients across 56 medical centers in China who underwent complete surgical resection. Participants were randomly assigned to receive either oral ensartinib or a placebo. The data revealed a 2-year disease-free survival rate of 86.4% for those treated with the drug, compared to 53.5% in the control group. Among the broader population of stage IB to IIIB patients, the hazard ratio for recurrence or death reached 0.20.
Ensartinib Significantly Cuts Recurrence Risk in ALK-Positive Lung Cancer
Patients with stage II to IIIB ALK-positive non-small cell lung cancer saw their risk of recurrence or death drop by 80% after receiving ensartinib as an adjuvant therapy. These findings from the ELEVATE study, published in The New England Journal of Medicine, offer a potential shift in standard postoperative care.
Betta Pharmaceuticals developed ensartinib as a selective next-generation ALK inhibitor. Following its approval in the United States in December 2024, the drug has been incorporated into the NCCN Guidelines for Non-Small Cell Lung Cancer. Dr. Ding Lieming, Chairman and CEO of Betta, noted that the publication confirms the clinical significance of the research as the company seeks marketing approval for this specific adjuvant indication in China and other global markets.
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